OBJECTIVE: To compare the efficacy of highly purified human urinary follicle stimulating hormone (HP-hFSH) versus human recombinant follitropin-alpha (rFSH) in volunteers undergoing controlled ovarian stimulation for IVF. DESIGN: A randomized, controlled, investigator-blind trial. SETTING: Four assisted reproductive technology centers. PATIENT(S): One hundred fifty-two IVF patients. INTERVENTION(S): Volunteers, aged 18-39, were randomized to HP-hFSH (n = 76) versus rFSH (n = 76) at a starting dose of 300 IU in down-regulated cycles. MAIN OUTCOME MEASURE(S): Number of oocytes, clinical pregnancy rate, and live birth rate with HP-hFSH versus rFSH. RESULT(S): The total IU of gonadotropin used did not differ between the two groups. There was no difference in number of oocytes retrieved with HP-hFSH (mean = 16.3) compared with rFSH (mean = 17.1), confidence interval (CI) of difference = -3.79 to +2.18. Clinical pregnancy rate, as defined by the presence of a gestational sac, was 48.7% (CI = 37.0%-60.4%) with HP-hFSH versus 44.7% (CI = 33.3%-56.6%) with rFSH (CI of difference = -11.9% to +19.8%). Live birth rate was 38.2% (29 of 76) in both groups (CI = 27.2%-50.0%), for a difference between groups of 0.0% (CI of the difference = -15.4% to +15.4%). CONCLUSION(S): There were no statistically significant differences in mean oocyte number, clinical pregnancy rate, or live birth rate between HP-hFSH versus rFSH.
RCT Entities:
OBJECTIVE: To compare the efficacy of highly purified human urinary follicle stimulating hormone (HP-hFSH) versus human recombinant follitropin-alpha (rFSH) in volunteers undergoing controlled ovarian stimulation for IVF. DESIGN: A randomized, controlled, investigator-blind trial. SETTING: Four assisted reproductive technology centers. PATIENT(S): One hundred fifty-two IVFpatients. INTERVENTION(S): Volunteers, aged 18-39, were randomized to HP-hFSH (n = 76) versus rFSH (n = 76) at a starting dose of 300 IU in down-regulated cycles. MAIN OUTCOME MEASURE(S): Number of oocytes, clinical pregnancy rate, and live birth rate with HP-hFSH versus rFSH. RESULT(S): The total IU of gonadotropin used did not differ between the two groups. There was no difference in number of oocytes retrieved with HP-hFSH (mean = 16.3) compared with rFSH (mean = 17.1), confidence interval (CI) of difference = -3.79 to +2.18. Clinical pregnancy rate, as defined by the presence of a gestational sac, was 48.7% (CI = 37.0%-60.4%) with HP-hFSH versus 44.7% (CI = 33.3%-56.6%) with rFSH (CI of difference = -11.9% to +19.8%). Live birth rate was 38.2% (29 of 76) in both groups (CI = 27.2%-50.0%), for a difference between groups of 0.0% (CI of the difference = -15.4% to +15.4%). CONCLUSION(S): There were no statistically significant differences in mean oocyte number, clinical pregnancy rate, or live birth rate between HP-hFSH versus rFSH.
Authors: Andrea F D Di Stefano; Antonio Rusca; Milko M Radicioni; Luca Loprete; Daniela Binelli; Giorgio Caccia; Barbara Cometti Journal: Clin Drug Investig Date: 2016-12 Impact factor: 2.859
Authors: Gianni Paulis; Luca Paulis; Gennaro Romano; Carmen Concas; Marika Di Sarno; Renata Pagano; Antonio Di Filippo; Maria Luisa Di Petrillo Journal: Res Rep Urol Date: 2017-10-30